ClinicalTrials.gov
ClinicalTrials.gov Menu

The Risk of Uncomplicated Peptic Ulcer in a Cohort of Secondary Prevention Aspirin Users

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01814943
Recruitment Status : Completed
First Posted : March 20, 2013
Last Update Posted : June 18, 2013
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:

This study is conducted in a cohort of low dose aspirin (ASA) users previously ascertained. The aims of the post hoc analyses are:

To estimate the incidence of uncomplicated peptic ulcer (UPU) in a cohort of low-dose ASA for secondary prevention of vascular disease and the relative risk of UPU associated with use and discontinuation of use of low dose ASA.

To estimate the effect of proton pump inhibitors (PPI) on the occurrence of UPU among users of low-dose ASA for secondary prevention of vascular disease To evaluate the effect of other risk factors on the occurrence of UPU among users of low-dose ASA for secondary prevention of vascular disease.


Condition or disease
Uncomplicated Peptic Ulcer

Detailed Description:
The risk of uncomplicated peptic ulcer in a cohort of secondary prevention aspirin users

Study Type : Observational
Actual Enrollment : 39000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Risk of Uncomplicated Peptic Ulcer in a Cohort of Secondary Prevention Aspirin Users
Study Start Date : November 2012
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Peptic Ulcer
Drug Information available for: Aspirin

Group/Cohort
Patients with prescription for low dose ASA (75-300 mg/day)



Primary Outcome Measures :
  1. Incidence rates of uncomplicated peptic ulcer in a cohort of secondary prevention aspirin users [ Time Frame: From 1 January 2000 till 30 September 2011, an expected average of 6 years. ]
  2. Risk (hazard ratio) of developing uncomplicated peptic ulcer in a cohort of secondary prevention aspirin users [ Time Frame: From 1 Januart 2000 till 30 September 2011, an expected average of 6 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 84 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients aged 50-84 yrs who had a first prescription of low-dose ASA (75-300mg/day) for secondary cardiovascular or cerebrovascular prevention in 2000-2007 in The Health Improvement Network database in the UK. Patients had to be enrolled with their PCP (Primary Care Physician) for at least 2 years and have a health contact in the year prior. Patients with use of aspirin ever recorded in the database before start of follow-up as well as patient with cancer or alcohol abuse were excluded. Individuals were followed up until the earliest occurrence of one of the following endpoints; first recorded diagnosis of uncomplicated peptic ulcer, canser, alcohol abuse or alcohol related disease, reaching the age of 85 years old, date of last practice data collection, death or end of follow-up ( 30 September 2011).Patient records were manually reviewed to validate cases.
Criteria

Inclusion Criteria:

- Patients aged 50-84 years in 2000-2007 with a first prescription of low dose ASA ( see study population description)

Exclusion Criteria:

- Patients aged below age 50 and 85 years and above ( see study population description)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01814943


Locations
Spain
Research Site
Madrid, Spain
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Luis A Garcia Rodriguez, MD CEIFE (Centro Espanol de Investigacion Farmacoepidemiologica - Spanish Centre for Pharmacoepidemiologic Research )

Publications:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01814943     History of Changes
Other Study ID Numbers: D5040N00007
First Posted: March 20, 2013    Key Record Dates
Last Update Posted: June 18, 2013
Last Verified: June 2013

Keywords provided by AstraZeneca:
Uncomplicated peptic ulcer
Acid-suppressing drugs
Epidemiology

Additional relevant MeSH terms:
Aspirin
Ulcer
Peptic Ulcer
Pathologic Processes
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics